After my last post on drugs, vitamins and expiration dates, I received an anonymous email from someone who claims to work in the pharmaceutical industry. They wanted to share some insider knowledge on how drug and vitamin expiration dates really work. A lot of it confirms and expands on what I wrote initially but includes some first hand knowledge that corroborates what I’ve only found researching online.

So while I can’t confirm he or she works in the pharmaceutical industry, I have no reason to believe (and I think you’ll agree) what he or she says is true.
As a person who works daily with the production of both Liquid and Solid Dose vitamins and all sorts of OTC pain relievers etc, I would almost consider myself an expert on this topic and wanted to give you the low down.

For all of the types of drugs and vitamins we make, the expiration date only holds one meaning: The date that my company will guarantee the legal claim efficacy of the drug. For example, certain vitamins degrade over time, so we put in a safe “overage” – knowing based on statistical stability data, etc, we will know that in X number of months, vitamin Y will degrade by a certain percentage. Our standard formulation process is to work backwards from 24 months and put in the correct amount of each vitamin, (or drug, same principle) so that at 24 months from the date of manufacture, all the nutrition or drug facts on the box are correct – that 24 month date is the expiration date on the box.

The only way for us to put a longer claim on the box is to have actual stability data (not statistical) – for example, if we haven’t changed the formula of the product or the bottle or tube it goes in for 3 years, and we do a bunch of testing on stuff that was made 3 years ago and it still meets the label claims, we can change the expiration date to 3 years. Unfortunately, this rarely happens because someone is always tweaking a formula or changing packaging materials for some reason or another, so its tough to do.

Oh, one other thing in response to a comment left by one of your readers – companies do not want short expiration dates – yeah, it might be nice to have someone have to go back to the store to by more drugs frequently, but there is way more risk for the company. Right now, I am managing roughly $150MM in finished product inventory, and I want as much time as I can to sell it. As it stands today, Walmart and most other retailers won’t accept product with less than 1 year of dating, so anything we can’t sell in that first 12 months after something’s made is usually destroyed.

If product is destroyed, not only is it a huge waste of money, I also have to make new product to replace what I just threw in the garbage – talk about waste.

Editor’s Note: So in summary, drugs and vitamins do work past their expiration date by quite a margin, but drug makers don’t label it as such because they aren’t able to meet the statutory requirements to prove that it does. I thought it was an interesting insider’s look, I hope you did too.

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Here’s the thing, there is an expiration date for a reason. Usually it’s benign, so if the cough syrup loses it’s effectiveness, no big deal.

But today, there are medicines where one isomer is beneficial, and the other is deadly. The beneficial isomer is usually an unnatural state, and will revert to it’s natural state (essentially equilibrium due to kinetics) which could be deadly. In low doses, it won’t affect you, but after time, it grows.

Not saying this happens in everything, but it’s one of the reasons you shouldn’t let stuff expire for too long before disposing of it.

This is just utterly untrue, and if you knew anything about organic synthesis (especially in drug discovery), you wouldn’t have posted your comment. It is much more likely for a compound to break down over time to other components rather than switch enantiomers.

It is true that the expiration dates are based on efficacy studies performed and validated by the company. The FDA reviews these claims and then allows the drug and vitamin manufacturers to state that the item is good until said date. You cannot state that something is still usable past a certain date unless you have data to back it up. This is basic science.

I have one word of caution. If a product is not regulated by the FDA, I would be a little bit more dubious of their claims as to the expiration date of their product.

Two thoughts (from someone who worked in a retail pharmacy for 6 years, and has a chemistry degree and work experience in pharmaceuticals):
1. His comment about inventory is very true. We would send back anything our supplier sent us that had less than 6 month shelf life per the expiration date. We were very concerned with expirations regarding inventory.
2. You will probably lose about 10% efficacy a month past expiration. I personally try to throw out anything that’s expired, but you’re not really hurting yourself taking ibuprofen thats old

Are you aware of any laws or regulations regarding receiving product with under 6 months remaining until expiration? i.e. – Receiving drug that has only 4 months left until expiration. Or is this just a good judgement call?

I guess it depends on the drug. If you get vitamins, which are supposed to last years, with only 4 months left then I’d return it and find another bottle. If it’s a ten day supply of an antibiotic that you’re supposed to finish in ten days, it doesn’t really matter when it expires (4 months, 4 years) since you will want to finish it in ten days.

In 1985, the military commissioned a study on expiration dates (FDA conducted), and found that over 90% of the drugs (OTC and prescription) it had stockpiled were safe and retained their efficacy far beyond their expiration dates.

There are also plenty of pharms which sell US regulated expired meds overseas, because they know the meds retain efficacy beyond US regulated requirements.

I’m not going to say to anyone to use meds past expiration date, especially since there are some meds that do lose efficacy (although i completely disagree with Tom’s blanket assertion that meds lose 10% each month past expiration, that is simply untrue). I always consider expiration dates as best use by dates just like foods. If properly stored (and meds should not be kept in the bathroom due to humidity), most meds can last.

Had no idea most vitamin supplements weren’t regulated, jus both some from vitasource comp, when I notice that the vitamin didn’t have a exp dd, I call them back to aks why..?? one of the manager got upset, but I rather buy my vitamin with exp DD.. Thanks.

What I think is funny about this discussion is that I would venture to gamble that most people do not look at expiration dates when taking any medications & (unfortunately) most people when they get better from an illness will stock pile on a prescribed medication and self-medicate. There is a placebo effect on every drug, so if you take a 6 year old codeine syrup and think it will work…well chances are it will work!

I go through the medicine cabinet usually once a year and throw away all expired medicine. Usually the ones that are expired are ones we didn’t find effective or ones we just didn’t like for some reason or another.

The revision in FDA policy for vitamins has changed. Previously a manufacturer could add up to 20% overage to a product to insure that it was at 100% of label claim at expiration. Additionally, a product was said to be compliant with label claims if it was 20% under stated potency at expiration.

FDA now does not allow any additional compensatory material at manufacturing and will not allow any deviation from label claim at expiration. Both of these are now considered to be violations of the Food Drug and Cosmetic Act and the product would be considered misbranded and /or adulterated.

The result is that vitamin type products will now appear with: 1) No expiration date since none is required or 2) a date of manufacture and a lot number but no expiration date.

This is true for dietary supplement but not for OTC drugs which were never permitted to have any variance in content.

Once a lot number has been assigned, which identifies the date of manufacture, and by extension -through internal company documentation- the raw materials that were used, an expiration date may be associated with that particular lot number. Once the expiration date is established for the specific lot number, it may not be changed.

Going forward one may expect to see vitamins with only the lot number and the date of manufacture but no expiration date. In other cases, there will be a lot number AND an expiration date. The difference has to do with the financial capability of the manufacturer to perform the testing required to substantiate the potency claim implicit in the expiration date.

I honestly could care less about vitamins exp. date. I’m trying to locate information relating to exp. dates on physician administered neurotoxins and any regulations or laws that prohibit manufacturers from distributing within a specific time frame (i.e. drug exp. date is 1 year from date of manufacturing, but can they legally distribute it after a certain point, say six months)? A lot of physician will not accept product that is less than six months from expiration, but is there a law to support refusing a product with only 3-4 months until expiration. Unable to find much information, any insight appreciated.

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